ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
- Registration Number
- NCT05507216
- Lead Sponsor
- Abivax S.A.
- Brief Summary
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 612
- Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects ≥ 18 years old will be enrolled. To be eligible, adolescent subjects must weigh ≥ 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
- Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
- Documented diagnosis of UC confirmed by endoscopy and histology. Should endoscopy/histology results not be available at screening, results from endoscopies and biopsies taken at screening may be used.
- Active disease defined by modified Mayo score (MMS) ≥ 5 with rectal bleeding subscore (RBS) ≥ 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
- Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic or biosimilar therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA or sulfasalazine is not accepted).
- Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with the contraception requirements described in the protocol.
- Subjects able and willing to comply with study visits and procedures as per protocol.
- Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.
-
Subjects with UC limited to an isolated proctitis (≤ 15cm from anal verge) determined by endoscopy central reading.
-
Subjects with primary sclerosing cholangitis or autoimmune hepatitis.
-
Subjects who have failed on 5-ASA or sulfasalazine therapy only.
-
Subjects with CD or presence or history of fistula, indeterminate colitis, infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis).
-
History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.
-
History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of colonic cancer or evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not).
-
Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.
-
Subjects on antidiarrheals including those working on motility (e.g., loperamide, diphenoxylate with atropine, etc.).
-
Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii).
-
Subjects who do not meet the washout period requirements prior to the screening endoscopy.
-
Subjects with the following hematological and biochemical laboratory parameters obtained during the screening period:
- Hemoglobin ≤ 8.0 g dL-1
- Absolute neutrophil count < 750 mm-3
- Platelets < 100,000 mm-3
- Creatinine clearance < 60 mL.min-1 (Cockroft-Gault formula)
- Total serum bilirubin > 1.5 x ULN
- Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN
-
Subjects with the following conditions (infection):
- Subjects with chronic or recurrent grade 3 or grade 4 infection within the last 2 months prior to screening or a history of opportunistic infection while not on immunosuppressive therapy.
- Herpes zoster reactivation within the last 2 months prior to screening.
- Subjects with active infection at screening or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 1 month of screening or during screening. Fungal infection of nail beds is allowed.
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridium difficile toxin at screening. If C. difficile is positive, subject may be treated and retested ≥ 2 weeks after completing treatment.
- Subjects with HIV infection.
- Subjects having acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen [HbsAg], or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable HBV DNA, or detectable HBV DNA).
- Subjects having acute or chronic hepatitis C infection at screening as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA [assessed centrally] are eligible).
- Active tuberculosis (TB) or untreated latent TB are ruled out. For subjects with positive or intermediate QuantiFERON test see the current study protocol.
-
Subjects with an uncontrolled ischemic heart disease and/or a history of congestive heart failure with New York Heart Association (NYHA) class 3 or 4 symptoms.
-
Subjects with a family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval [Fridericia or Bazett correction] >450 milliseconds for male and > 460 milliseconds for female).
-
Subjects with a history of torsade de pointe (TdP).
-
Acute or chronic of clinically relevant pulmonary, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history (note: treated autoimmune hypothyroidy and autoimmune diabetes are allowed).
-
Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare).
-
Subjects previously treated with ABX464.
-
Subjects with a known hypersensitivity to the active substance or to any of the excipients.
-
WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study, or male subject with WOCBP partner who intends to be pregnant during the study.
-
Illicit drug or alcohol abuse or dependence.
-
Subjects who received live vaccine within 3 months prior to screening and/or who's planning to receive such a vaccine during the study duration.
-
Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer, and during the study.
-
Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
-
Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks ABX464 50mg ABX464 Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks ABX464 25mg ABX464 Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8 8 weeks To compare the efficacy of ABX464 versus placebo on clinical remission
- Secondary Outcome Measures
Name Time Method Proportion of subjects who achieve clinical response per MMS at week 8 8 weeks To compare the efficacy of ABX464 versus placebo on clinical response as per MMS
Proportion of subjects with HEMI per Geboes at week 8 8 weeks To compare the efficacy of ABX464 versus placebo on histologic-endoscopic mucosal improvement (HEMI)
Proportion of subjects who achieve endoscopic improvement at week 8 8 weeks To compare the efficacy of ABX464 versus placebo on endoscopic improvement
Proportion of subjects with symptomatic remission at week 8 8 weeks To compare the efficacy of ABX464 versus placebo on symptomatic remission
Trial Locations
- Locations (273)
Ocala GI Research
🇺🇸Ocala, Florida, United States
Sarkis Clinical Trials - Parent
🇺🇸Ocala, Florida, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Accelerium S de RL de CV
🇲🇽Monterrey, Nuevo León, Mexico
Showa University Koto Toyosu Hospital
🇯🇵Koto-ku, Tokyo-To, Japan
Fakultna nemocnica Nitra
🇸🇰Nitra, Slovakia
Svet zdravia a.s.
🇸🇰Rimavská Sobota, Slovakia
DRK Kliniken Berlin Westend
🇩🇪Berlin, Germany
Clinfan Szolgaltato Kft.
🇭🇺Szekszárd, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
🇭🇺Kaposvár, Hungary
Okayama University Hospital
🇯🇵Okayama-shi, Okayama-Ken, Japan
NHO Okayama Medical Center
🇯🇵Okayama-shi, Okayama-Ken, Japan
Nicklaus Children's Hospital
🇺🇸Miami, Florida, United States
Sanchez Clinical Research, Inc
🇺🇸Miami, Florida, United States
Valley Institute of Research
🇺🇸Fort Worth, Texas, United States
Mt.Olympus Medical Research
🇺🇸Katy, Texas, United States
Centro de Investigacion CICE
🇦🇷San Miguel De Tucumán, Tucuman, Argentina
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
AZ Maria Middelares
🇧🇪Gent, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
GZA Ziekenhuizen
🇧🇪Antwerpen, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
🇧🇷Fortaleza, Ceará, Brazil
Digestive Health Research, LC
🇺🇸Hermitage, Tennessee, United States
Centro de Investigaciones Medicas Tucuman
🇦🇷San Miguel De Tucumán, Tucuman, Argentina
Gastroenterología Diagnóstica y Terapéutica (Gedyt)
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
CEMIC
🇦🇷Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Tyler Research Institute, LLC
🇺🇸Tyler, Texas, United States
AZ Sint-Lucas
🇧🇪Gent, Belgium
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
DCC 'Sv. Pantaleymon' OOD
🇧🇬Pleven, Bulgaria
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
🇧🇷Botucatu, Sao Paulo, Brazil
MC Medica Plus
🇧🇬Veliko Tarnovo, Bulgaria
Institut klinicke a experimentalni mediciny
🇨🇿Praha, Czechia
CHU Caen - Hôpital de la Côte de Nacre
🇫🇷Caen, Calvados, France
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Hospital de brabois
🇫🇷Vantoux, Moselle, France
Obudai Egeszsegugyi Centrum Kft.
🇭🇺Dunaujvaros, Hungary
Krajska nemocnice T. Bati a.s.
🇨🇿Zlín, Czechia
Digestive System Healthcare
🇺🇸Pasadena, Texas, United States
LinQ Research, LLC
🇺🇸Pearland, Texas, United States
Pesquisare Saúde
🇧🇷Santo André, Sao Paulo, Brazil
CDC - Centro Digestivo de Curitiba
🇧🇷Curitiba, Paraná, Brazil
Hopital Rangueil
🇫🇷Toulouse, Haute Garonne, France
Diagnostic Consultation Center CONVEX EOOD
🇧🇬Sofia, Bulgaria
General Hospital "Dr.Tomislav Bardek" Koprivnica
🇭🇷Koprivnica, Croatia
University hospital centre Zagreb
🇭🇷Zagreb, Croatia
Universitaetsklinikum Augsburg
🇩🇪Augsburg, Bayern, Germany
Faculdade de Medicina do ABC
🇧🇷Santo André, Sao Paulo, Brazil
(G.I.R.I.) GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
Hopital Maisonneuve-Rosemont d/b/a CIUSSS de l'Est-de-l'Île-de-Montréal
🇨🇦Montréal, Quebec, Canada
Poliklinika Borzan d.o.o
🇭🇷Osijek, Croatia
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
General Hospital Zadar
🇭🇷Zadar, Croatia
Solmed Polyclinic
🇭🇷Zagreb, Croatia
CHU Nice - Hôpital de l'Archet 2
🇫🇷Nice, Alpes Maritimes, France
Fakultni nemocnice Ostrava
🇨🇿Ostrava, Czechia
CECIP - Centro de Estudos Clínicos do Interior Paulista
🇧🇷Jaú, Sao Paulo, Brazil
Irmandade da Santa Casa da Misericórdia de Santos
🇧🇷Santos, Sao Paulo, Brazil
Lakeshore Hospital and Research Centre Ltd.
🇮🇳Cochin, Kerala, India
Soroka University Medical Center
🇮🇱Be'er Sheva, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Vinaya Hospital and Research Center
🇮🇳Mangalore, Karnataka, India
University Hospital Galway
🇮🇪Galway, Ireland
Fukuoka University Chikushi Hospital
🇯🇵Chikushino-shi, Fukuoka-Ken, Japan
Kagoshima IBD Gastroenterology Clinic
🇯🇵Kagoshima-shi, Kagoshima-Ken, Japan
Keiaikai Nakagami Hospital
🇯🇵Okinawa-shi, Okinawa-Ken, Japan
Saga-Ken Medical Centre Koseikan
🇯🇵Saga-shi, Saga-Ken, Japan
Centrul Medical Renasterea Craiova
🇷🇴Craiova, Romania
Midland Regional Hospital
🇮🇪Mullingar, Westmeath, Ireland
Bnai Zion Medical Center
🇮🇱Haifa, Israel
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
🇮🇹Milano, Italy
Aso Co.,Ltd Iizuka Hospital
🇯🇵Iizuka-shi, Fukuoka-Ken, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima-shi, Hiroshima-Ken, Japan
Postgraduate Institute of Medical Education and Research
🇮🇳Chandigarh, India
Connolly Hospital
🇮🇪Dublin, Ireland
Rabin Medical Center-Beilinson Campus
🇮🇱Petah tikva, Israel
Kiryu Kosei General Hospital
🇯🇵Kiryu-shi, Gunma-Ken, Japan
JA-Hiroshima General Hospital
🇯🇵Hatsukaichi-shi, Hiroshima-Ken, Japan
NHO Mito Medical Center
🇯🇵Ibaraki, Ibaraki-Ken, Japan
Takamatsu Red Cross Hospital
🇯🇵Takamatsu-shi, Kagawa-Ken, Japan
Jiaikai Izuro Imamura Hospital
🇯🇵Kagoshima-shi, Kagoshima-Ken, Japan
NHO Ureshino Medical Center
🇯🇵Ureshino-shi, Saga-Ken, Japan
Sociedad de Metabolismo y Corazon S.C
🇲🇽Veracruz, Mexico
Auckland City Hospital
🇳🇿Grafton, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Saga University Hospital
🇯🇵Saga-shi, Saga-Ken, Japan
Tauranga Hospital
🇳🇿Tauranga, New Zealand
Centro Medico Teknon
🇪🇸Barcelona, Spain
Matsuaikai Matsuda Hospital
🇯🇵Hamamatsu-shi, Shizuoka-Ken, Japan
Centrum Medyczne Plejady
🇵🇱Kraków, Poland
Hospital Universitari de Girona Dr Josep Trueta
🇪🇸Girona, Spain
NZOZ Centrum Medyczne KERmed
🇵🇱Bydgoszcz, Poland
Hospital General Juan Ramon Jimenez
🇪🇸Huelva, Spain
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
🇵🇱Knurów, Poland
SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
🇷🇴Bucuresti, Romania
Hospital Universitario de Fuenlabrada
🇪🇸Fuenlabrada, Madrid, Spain
Wojewodzki Specjalistyczny Szpital w Olsztynie
🇵🇱Olsztyn, Poland
Gabinet Lekarski Bartosz Korczowski
🇵🇱Rzeszów, Poland
S.C Pelican Impex S.R.L
🇷🇴Oradea, Romania
Endomed, s.r.o.
🇸🇰Košice, Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
🇸🇰Banská Bystrica, Slovakia
Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
Gastro I, s.r.o.
🇸🇰Prešov, Slovakia
Complejo Hospitalario Universitario de Ferrol
🇪🇸Ferrol, La Coruña, Spain
Hospital Montecelo
🇪🇸Pontevedra, Spain
Hospital Aliança
🇧🇷Salvador, Bahia, Brazil
L2IP - Instituto de Pesquisas Clínicas Ltda.
🇧🇷Brasília, Distrito Federal, Brazil
Maharaja Agrasen Hospital
🇮🇳New Delhi, Delhi, India
Fortis Escorts Heart Institute and Research Centre
🇮🇳New Delhi, Delhi, India
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
Plains Clinical Research Center, LLC
🇺🇸Fargo, North Dakota, United States
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Hôpital Nord - CHU Marseille
🇫🇷Marseille, Bouches-du-Rhône, France
Consultorio Medico, InvesclinicMX
🇲🇽Irapuato, Guanajuato, Mexico
Hospital Ernesto Dornelles
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Mater Domini
🇮🇹Catanzaro, Italy
Università Campus Bio-Medico di Roma
🇮🇹Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Roma, Italy
University of Alabama -Birmingham
🇺🇸Birmingham, Alabama, United States
Valleywise Health Medical Center
🇺🇸Phoenix, Arizona, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
Board of Regents of the University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Praxis Pesquisa Medica
🇧🇷Santo André, Sao Paulo, Brazil
Hepatogastro
🇧🇷São Paulo, Sao Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos - CEMEC
🇧🇷São Bernardo, Sao Paulo, Brazil
Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals
🇺🇸Aurora, Colorado, United States
GCP Clinical Research, LLC
🇺🇸Tampa, Florida, United States
Guardian Angel Research Center
🇺🇸Tampa, Florida, United States
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
🇺🇸Roanoke, Virginia, United States
The Vancouver Clinic
🇺🇸Vancouver, Washington, United States
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Arnold Palmer Hospital For Children
🇺🇸Orlando, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Research Solutions of Arizona, PC
🇺🇸Litchfield Park, Arizona, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
National Institute of Clinical Research
🇺🇸Bakersfield, California, United States
Kindred Medical Institute for Clinical Trials, LLC
🇺🇸Corona, California, United States
Citrus Valley Gastroenterology
🇺🇸Covina, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
United Medical Doctors
🇺🇸Murrieta, California, United States
Clinical Applications Laboratories
🇺🇸San Diego, California, United States
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
West Central Gastroenterology d/b/a Gastro Florida
🇺🇸Clearwater, Florida, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Superior Associates in Research
🇺🇸Hialeah, Florida, United States
IHS Health
🇺🇸Kissimmee, Florida, United States
Infinite Clinical Research Inc
🇺🇸Miami, Florida, United States
Research Associates of South Florida
🇺🇸Miami, Florida, United States
Reliant Medical Research, LLC
🇺🇸Miami, Florida, United States
Alliance Clinical Research
🇺🇸Tampa, Florida, United States
Omega Research Orlando, LLC
🇺🇸Orlando, Florida, United States
The University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
NECCR Primacare Research, LLC
🇺🇸Fall River, Massachusetts, United States
Michigan Center of Medical Research
🇺🇸Farmington Hills, Michigan, United States
BVL Clinical Research
🇺🇸Liberty, Missouri, United States
Gastrointestinal Associates, PA
🇺🇸Flowood, Mississippi, United States
AIG Digestive Disease Research
🇺🇸Florham Park, New Jersey, United States
NY Scientific Corp.
🇺🇸Brooklyn, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Mount Sinai
🇺🇸New York, New York, United States
Susquehanna Research Group, LLC
🇺🇸Harrisburg, Pennsylvania, United States
Frontier Clinical Research, LLC
🇺🇸Uniontown, Pennsylvania, United States
Rapid City Medical Center, LLC
🇺🇸Rapid City, South Dakota, United States
Institut des MICI
🇫🇷Neuilly, Hauts De Seine, France
CHU Rennes - Hôpital Pontchaillou
🇫🇷Rennes, Ille Et Vilaine, France
CHU de Grenoble - Hôpital Nord
🇫🇷Grenoble, Isere, France
CHU Amiens - Hopital Sud
🇫🇷Amiens, Somme, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, Rhone, France
Medius Klinik Nuertingen
🇩🇪Nürtingen, Baden Wuerttemberg, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Baden Wuerttemberg, Germany
INLUGA im Haus der Gesundheit
🇩🇪Ludwigshafen, Rheinland Pfalz, Germany
Charité - Campus Charité Mitte
🇩🇪Berlin, Germany
Hamburgisches Forschungsinstitut fure Chronische Darmerkrankungen
🇩🇪Hamburg, Germany
Krankenhaus Waldfriede e. V.
🇩🇪Berlin, Germany
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
🇭🇺Debrecen, Hungary
Yashoda Super Speciality Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Gandhi Hospital
🇮🇳Secunderabad, Andhra Pradesh, India
Origin Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Surat Institute of Digestive Sciences
🇮🇳Surat, Gujarat, India
Gujarat Hospital
🇮🇳Sūrat, Gujarat, India
Isha Multispeciality Hospital
🇮🇳Vadodara, Gujarat, India
Lokmanya Tilak Municipal General Hospital & Medical College
🇮🇳Mumbai, Maharashtra, India
SRM Institutes for Medical Sciences
🇮🇳Chennai, Tamilnadu, India
Kaplan Medical Center KMC Institute of Gastroenterology and Liver Diseases
🇮🇱Reẖovot, Israel
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Ospedale di Circolo
🇮🇹Rho, Milano, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
🇮🇹Napoli, Italy
Toyohashi Municipal Hospital
🇯🇵Toyohashi, Aichi-Ken, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama-shi, Ehime-Ken, Japan
Kokikai Tsujinaka Hospital Kashiwanoha
🇯🇵Kashiwa-shi, Chiba-Ken, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka-Ken, Japan
Our Lady of the Snow St. Mary's Hospital
🇯🇵Kurume-shi, Fukuoka-Ken, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
🇯🇵Ota-shi, Gunma-Ken, Japan
NHO Fukuyama Medical Center
🇯🇵Fukuyama-shi, Hiroshima-Ken, Japan
JCHO Hokkaido Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Aoyama Clinic
🇯🇵Kobe-shi, Hyogo-Ken, Japan
NHO Kanazawa Medical Center
🇯🇵Kanazawa-shi, Ishikawa-Ken, Japan
Kawasaki Municipal Hospital
🇯🇵Kawasaki-shi, Kanagawa-Ken, Japan
Sameshima Hospital
🇯🇵Kagoshima-shi, Kagoshima-Ken, Japan
Gokeikai Ofuna Chuo Hospital
🇯🇵Kamakura-shi, Kanagawa-Ken, Japan
Showa University Northern Yokohama Hospital
🇯🇵Yokohama-shi, Kanagawa-Ken, Japan
Ishida Clinic of IBD and Gastroenterology
🇯🇵Oita-shi, Oita-Ken, Japan
Mie University Hospital
🇯🇵Tsu-shi, Mie-Ken, Japan
Saiseikai Niigata Hospital
🇯🇵Niigata-shi, Niigata-Ken, Japan
Shinseikai Sai Gastroenterology, Proctology Clinic
🇯🇵Fujiidera, Osaka-Fu, Japan
Kinshukai Infusion Clinic
🇯🇵Osaka-shi, Osaka-Fu, Japan
JCHO Osaka Hospital
🇯🇵Osaka-shi, Osaka-Fu, Japan
NHO Osaka National Hospital
🇯🇵Osaka-shi, Osaka-Fu, Japan
Kumagaya General Hospital
🇯🇵Kumagaya-shi, Saitama-Ken, Japan
Kitasato University Kitasato Institute Hospital
🇯🇵Minato-ku, Tokyo-To, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
🇱🇹Kaunas, Lithuania
Klaipeda University Hospital branch "Seamen's Hospital"
🇱🇹Klaipėda, Lithuania
FAICIC S. de R.L. de C.V.
🇲🇽Veracruz, Mexico
Christchurch Hospital NZ
🇳🇿Christchurch, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand
Centrum Medyczne Pratia Gdynia
🇵🇱Gdynia, Poland
Trialmed CRS
🇵🇱Kalisz, Poland
ETG Kielce Zagorska
🇵🇱Kielce, Poland
1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ w Lublinie
🇵🇱Lublin, Poland
Centrum Zdrowia Tuchow Sp. z o.o.
🇵🇱Wierzchosławice, Poland
DC-MED
🇵🇱Świdnica, Poland
Spitalul de Oncologie Monza
🇷🇴Bucharest, Romania
Spitalul Clinic Colentina
🇷🇴Bucuresti, Romania
Lotus Med SRL
🇷🇴Bucuresti, Romania
S.C Policlinica CCBR S.R.L
🇷🇴Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
🇷🇴Cluj-Napoca, Romania
HaEmek Medical Center
🇮🇱Afula, Israel
Reliance Research
🇺🇸Scottsdale, Arizona, United States
Carmel Medical Center
🇮🇱Haifa, Israel
CHU Lille - Hôpital Claude Huriez
🇫🇷Lille, Nord, France
Centre Hospitalier Départemental Les Oudairies
🇫🇷La Roche-sur-Yon, Vendée, France
Gyongyosi Bugat Pal Korhaz
🇭🇺Gyöngyös, Hungary
Portiuncula Hospital
🇮🇪Galway, Ireland
Our Lady of Lourdes
🇮🇪Louth, Ireland
Institute of Post Graduate Medical Education And Research
🇮🇳Kolkata, West Bengal, India
NHO Kure Medical Center and Chugoku Cancer Center
🇯🇵Kure-shi, Hiroshima-Ken, Japan
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu-shi, Kagawa-Ken, Japan
Kaiseikai Hattori Clinic
🇯🇵Kumamoto-shi, Kumamoto-Ken, Japan
Inspirepharma S. de R.L. de C.V.
🇲🇽Monterrey, Nuevo León, Mexico
JCHO Tokyo Yamate Medical Center
🇯🇵Shinjuku-ku, Tokyo-To, Japan
Lithuanian University of Health Sciences Kaunas Hospital
🇱🇹Kaunas, Lithuania
ALLMEDICA sp. z o. o.
🇵🇱Nowy Targ, Poland
Medicome Sp. z o.o.
🇵🇱Oswiecim, Poland
Nowe zdrowie-CK, Kieltucki i wspolnicy sp. j.
🇵🇱Staszów, Poland
S.C Delta Health Care S.R.L
🇷🇴Bucuresti, Romania
Institutul Clinic Fundeni
🇷🇴Bucuresti, Romania
S.C Centrul Medical Valahia S.R.L
🇷🇴Ploieşti, Romania
Clinical Center " Dr Dragisa Misovic Dedinje"
🇷🇸Belgrade, Serbia
Clinical Hospital Center Zvezdara
🇷🇸Belgrade, Serbia
General Hospital Subotica
🇷🇸Subotica, Serbia
Cliniq s.r.o.
🇸🇰Bratislava, Slovakia
KM Management spol. s r.o.
🇸🇰Nitra, Slovakia
Gastro LM s.r.o.
🇸🇰Prešov, Slovakia
Accout Center s.r.o.
🇸🇰Šahy, Slovakia
Addenbrooke's Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
🇬🇧Exeter, Devon, United Kingdom
Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)
🇧🇷Caxias Do Sul, Rio Grande Do Sul, Brazil
Tandem Clinical Research, LLC
🇺🇸Marrero, Louisiana, United States
Datta Meghe Institute of Medical Sciences (Deemed University)
🇮🇳Wardha, Maharashtra, India
Hospital Universitario de Gran Canaria Dr. Negrin
🇪🇸Las Palmas De Gran Canaria, Las Palmas, Spain
Guy's Hospital
🇬🇧London, Greater London, United Kingdom